colgate®

colgate®
SPL v8
SPL
SPL Set ID 0b90a131-7933-4501-a174-e35aa95b56c3
Route
dental
Published
Effective Date 2019-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1 mg)
Inactive Ingredients
propylene glycol calcium pyrophosphate povidone k15 peg/ppg-116/66 copolymer hydrogen peroxide sodium lauryl sulfate sodium pyrophosphate saccharin sodium sodium acid pyrophosphate silicon dioxide sucralose butylated hydroxytoluene

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug completed Since 2019-11-04 Until 2024-12-31

Purpose

Anticavity

Description

Drug Facts


Medication Information

Purpose

Anticavity

Directions
adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 years ask a dentist or physician
Inactive Ingredients

Propylene Glycol, Calcium Pyrophosphate, PVP, PEG/PPG-116/66 Copolymer, Hydrogen Peroxide, Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, Silica, Sucralose, BHT.

Description

Drug Facts

Questions?

1-800-468-6502

Use

helps protect against cavities

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient

Sodium Monofluorophosphate 0.76% (0.12% w/v fluoride ion)

Principal Display Panel 85 G Tube Carton

Colgate®

Anticavity Fluoride Toothpaste

NEW

OPTIC

WHITE®

RENEWAL

REMOVES

10 YEARS OF

YELLOW STAINS*

HYDROGEN

3%

PEROXIDE

HIGH IMPACT WHITE

NET WT 3.0 OZ (85 g)

ENAMEL SAFE


Structured Label Content

Purpose

Anticavity

Directions
adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 years ask a dentist or physician
Inactive Ingredients (Inactive ingredients)

Propylene Glycol, Calcium Pyrophosphate, PVP, PEG/PPG-116/66 Copolymer, Hydrogen Peroxide, Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, Silica, Sucralose, BHT.

Questions?

1-800-468-6502

Use

helps protect against cavities

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient (Active ingredient)

Sodium Monofluorophosphate 0.76% (0.12% w/v fluoride ion)

Principal Display Panel 85 G Tube Carton (PRINCIPAL DISPLAY PANEL - 85 g Tube Carton)

Colgate®

Anticavity Fluoride Toothpaste

NEW

OPTIC

WHITE®

RENEWAL

REMOVES

10 YEARS OF

YELLOW STAINS*

HYDROGEN

3%

PEROXIDE

HIGH IMPACT WHITE

NET WT 3.0 OZ (85 g)

ENAMEL SAFE


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)